loading page

Adverse Fetal and Neonatal Outcomes following in-utero exposure to Oxcarbazepine: A Systematic Review and Meta-Analysis.
  • +5
  • Farwa Athar,
  • Muhammad Ehsan,
  • Minaam Farooq,
  • Kevin Lo,
  • Huzaifa Cheema,
  • Shahzaib Ahmad,
  • Aiman Naveed,
  • Muhammad Umer
Farwa Athar
King Edward Medical University

Corresponding Author:farwakemu@gmail.com

Author Profile
Muhammad Ehsan
King Edward Medical University
Author Profile
Minaam Farooq
King Edward Medical University
Author Profile
Kevin Lo
Albert Einstein Medical Center Philadelphia
Author Profile
Huzaifa Cheema
King Edward Medical University
Author Profile
Shahzaib Ahmad
King Edward Medical University
Author Profile
Aiman Naveed
King Edward Medical University
Author Profile
Muhammad Umer
King Edward Medical University
Author Profile

Abstract

Aim: This systematic review aims to assess the safety profile of oxcarbazepine during pregnancy. Methods: Observational studies that included women who took oxcarbazepine anytime during pregnancy were included in our systematic review. The review did not include non-English articles, reviews, meta-analyses, case reports, and animal studies. Different online sources such as MEDLINE, Cochrane library, Virtual Health library etc. were searched for published and unpublished literature. Assessment of risk of bias of observational studies was done using the Newcastle-Ottawa Scale. The meta-analyses were performed using a random-effect model. GRADE was used for the evaluation of the quality of evidence for the primary outcomes. Results: We included 19 cohort studies with a total number of 5,071,137 patients, of which 2,450 were exposed to oxcarbazepine either as monotherapy or polytherapy. The summary odds ratio (OR) was 1.69 (95% CI, 0.95-2.98) for congenital malformations following in-utero exposure to oxcarbazepine as compared to the control group of unexposed patients [seven studies (n=625)], and was 1.19 (95% CI, 0.67-2.12) when compared to those following lamotrigine (LTG) exposure during pregnancy [3 studies (n=591)]. In total, three studies (n=770) reported the association between in-utero oxcarbazepine exposure and fetal/perinatal deaths. The meta-analysis yielded a summary OR of 3.11 (95% CI, 0.57-16.97). Significance: Our systematic review will help healthcare providers and guideline developers regarding the treatment of epilepsy and other neurological disorders during pregnancy. More cohort studies with a higher sample size concerning oxcarbazepine use in pregnant patients are required to truly assess the in-utero safety profile of the drug.
27 Jan 2022Submitted to British Journal of Clinical Pharmacology
28 Jan 2022Submission Checks Completed
28 Jan 2022Assigned to Editor
11 Feb 2022Reviewer(s) Assigned
13 Apr 2022Review(s) Completed, Editorial Evaluation Pending
19 Apr 2022Editorial Decision: Revise Major
08 May 20221st Revision Received
09 May 2022Submission Checks Completed
09 May 2022Assigned to Editor
09 May 2022Review(s) Completed, Editorial Evaluation Pending
15 May 2022Editorial Decision: Accept
Aug 2022Published in British Journal of Clinical Pharmacology volume 88 issue 8 on pages 3600-3609. 10.1111/bcp.15413